METEOR Think NIV Pilot

NCT04052542 | Completed Results DMC

• 2 other identifiers: STUDY19050064U01HL143507
• Study Type: interventional
• Target: 1,328
• Locations: 1 country
• Sites: 1

Brief Summary

This study will pilot test three strategies designed to speed implementation of preventive post-extubation noninvasive ventilation (NIV): one control strategy (traditional online continuing medical education) and two novel strategies (interprofessional education and just-in-time education).

Conditions

Acute Respiratory Failure

Keywords

Noninvasive ventilation; Education; Intensive care unit; Mechanical ventilation; Evidence-based practice

Outcome Measures

Primary Outcomes (2)

• Number of ICU Team Members (Learners) Who Received Education

  This implementation outcome measuring reach only applies to learner participants.

  Up to 1 month

• Learner Attitudes Regarding Education (Mean Scores on Relevant Survey Questions)

  Using a 5-point Likert scale (1=strongly disagree; 5=strongly agree), learners reported their level of agreement with the statement "I liked the way the information was presented." This outcome only applies to learner participants.

  Up to 10 weeks

Secondary Outcomes (7)

• Number of High-risk Patients Without Contraindications Who Received Post-extubation Noninvasive Ventilation

  Participants will be followed for the duration of their hospital admission, estimated to be 1-2 weeks

• Learner Role Clarity (Mean Scores on Relevant Survey Questions)

  Up to 10 weeks

• Learner Specialization (Mean Scores on Relevant Survey Questions)

  Up to 10 weeks

• Learner Credibility (Mean Scores on Relevant Survey Questions)

  Up to 10 weeks

• Learner Coordination (Mean Scores on Relevant Survey Questions)

  Up to 10 weeks

Study Arms (3)

Traditional online continuing education

ACTIVE COMPARATOR

Behavioral: Traditional online continuing education

Interprofessional education

ACTIVE COMPARATOR

Behavioral: Interprofessional education

Just-in-time education

ACTIVE COMPARATOR

Behavioral: Just-in-time education

Interventions

Traditional online continuing education BEHAVIORAL

30-minute, online, interactive, educational video describing the benefits of preventive post-extubation NIV, the indications and contraindications for preventive post-extubation NIV, and the value of working together as an interprofessional ICU team when implementing preventive post-extubation NIV

Traditional online continuing education

Interprofessional education BEHAVIORAL

One-time, 90-120-minute, in-person, interprofessional educational workshop consisting of a 30-minute didactic session and a 60-90-minute small group session

Interprofessional education

Just-in-time education BEHAVIORAL

"Just-in-time," point-of-care education provided by trained advanced practice providers who will be on-hand in the study ICU, where they will deliver the education at the bedside during rounds when a patient meets criteria for preventive post-extubation NIV

Just-in-time education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Two study populations will be included. Learners (population 1) will include: * frontline care providers, including physicians, advanced practice providers, nurses, and respiratory therapists * working in a participating ICU. Frontline care providers will be excluded if they: * have not worked in their current UPMC ICU for more than one month prior to the current study * have not directly cared for a mechanically ventilated patient in a UPMC ICU during the three months preceding the current study. Patients (population 2) will include: * mechanically ventilated patients * treated in the participating ICUs * surviving to extubation

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (4)

• Thille AW, Harrois A, Schortgen F, Brun-Buisson C, Brochard L. Outcomes of extubation failure in medical intensive care unit patients. Crit Care Med. 2011 Dec;39(12):2612-8. doi: 10.1097/CCM.0b013e3182282a5a.

  PMID: 21765357 BACKGROUND

• Ferrer M, Sellares J, Valencia M, Carrillo A, Gonzalez G, Badia JR, Nicolas JM, Torres A. Non-invasive ventilation after extubation in hypercapnic patients with chronic respiratory disorders: randomised controlled trial. Lancet. 2009 Sep 26;374(9695):1082-8. doi: 10.1016/S0140-6736(09)61038-2. Epub 2009 Aug 12.

  PMID: 19682735 BACKGROUND

• Ouellette DR, Patel S, Girard TD, Morris PE, Schmidt GA, Truwit JD, Alhazzani W, Burns SM, Epstein SK, Esteban A, Fan E, Ferrer M, Fraser GL, Gong MN, Hough CL, Mehta S, Nanchal R, Pawlik AJ, Schweickert WD, Sessler CN, Strom T, Kress JP. Liberation From Mechanical Ventilation in Critically Ill Adults: An Official American College of Chest Physicians/American Thoracic Society Clinical Practice Guideline: Inspiratory Pressure Augmentation During Spontaneous Breathing Trials, Protocols Minimizing Sedation, and Noninvasive Ventilation Immediately After Extubation. Chest. 2017 Jan;151(1):166-180. doi: 10.1016/j.chest.2016.10.036. Epub 2016 Nov 3.

  PMID: 27818331 BACKGROUND

• Rochwerg B, Brochard L, Elliott MW, Hess D, Hill NS, Nava S, Navalesi P Members Of The Steering Committee, Antonelli M, Brozek J, Conti G, Ferrer M, Guntupalli K, Jaber S, Keenan S, Mancebo J, Mehta S, Raoof S Members Of The Task Force. Official ERS/ATS clinical practice guidelines: noninvasive ventilation for acute respiratory failure. Eur Respir J. 2017 Aug 31;50(2):1602426. doi: 10.1183/13993003.02426-2016. Print 2017 Aug.

  PMID: 28860265 BACKGROUND

Limitations and Caveats

By design, this was a non-randomized pilot trial intended to assess the feasibility, acceptability, and preliminary impact of three strategies designed to speed implementation of post-extubation noninvasive ventilation among high-risk patients recovering from acute respiratory failure. The effects of the educational interventions on patient outcomes cannot be reliably determined using data from this trial.

Results Point of Contact

• Title: Timothy D Girard, MD, MSCI
• Organization: University of Pittsburgh School of Medicine

timothy.girard@pitt.edu

(412) 383-0582

Study Officials

• Timothy D Girard, MD, MSCI

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 9, 2019
• Study Start: August 28, 2019
• Primary Completion: November 20, 2019
• Study Completion: November 20, 2019
• Last Updated: October 6, 2021
• Results First Posted: September 17, 2021

Record last verified: 2021-09

Locations

US (1)